Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
60 participants
OBSERVATIONAL
2017-11-09
2020-10-05
Brief Summary
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Detailed Description
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Knee repair:
* ACL repair Posterior cruciate ligament (PCL) repair
* Extra-capsular repairs
* Medial collateral ligament (MCL)
* Lateral collateral ligament (LCL)
* Posterior oblique ligament (POL)
* Patellar realignment and tendon repairs
* Vastus medialis obliquus advancement
* Iliotibial band tenodesis
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. Subject is eighteen (18) years of age or older at the time of enrollment in the study.
3. Subject requires one of the following knee procedures:
* Anterior cruciate ligament (ACL) repair
* Posterior cruciate ligament (PCL) repair
* Extra-capsular repair - Medial collateral ligament (MCL), Lateral collateral ligament (LCL), Posterior oblique ligament (POL)
* Patellar realignment and tendon repair Vastus medialis obliquus advancement Iliotibial band tenodesis
4. Subject is willing and able to comply with study visit schedule and to complete study procedures and questionnaires.
Exclusion Criteria
2. Subject has had total knee arthroplasty (TKA) in the study knee.
3. Subject has conditions that may interfere with graft survival or outcome (e.g. Paget disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease).
4. Subject has a known allergy to the study device or any of its components.
5. Subject, in the opinion of the Investigator, has an emotional or neurological condition that would pre-empt their willingness to participate in the study, including mental illness, mental retardation, drug or alcohol abuse, subject is pregnant, or plans to become pregnant during the study.
6. Subject is entered in another investigational drug, biologic, or device study, or has been treated with an investigational product in the past 30 days.
7. Subject is known to be at risk for loss to follow-up or failure to return for scheduled visits.
18 Years
ALL
No
Sponsors
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Smith & Nephew, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Stephan Mangin
Role: STUDY_CHAIR
Smith & Nephew, Inc.
Locations
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OrthoIllinois
Rockford, Illinois, United States
OrthoCarolina Research Institute, Inc.
Charlotte, North Carolina, United States
Kelsey-Seybold Clinic/ Kelsey Research Foundation
Houston, Texas, United States
Countries
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Other Identifiers
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16-5010-16
Identifier Type: -
Identifier Source: org_study_id
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